Cost-effectiveness of a tailored Helicobacter pylori eradication strategy based on the presence of a 23S ribosomal RNA point mutation that causes clarithromycin resistance in Korean patients.

BACKGROUND AND AIM: The Helicobacter pylori eradication rate using conventional triple therapy has decreased due to clarithromycin (CAM) resistance in H. pylori. Recently, dual priming oligonucleotide (DPO)-based multiplex polymerase chain reaction (PCR) can be used to detect H. pylori and point mutations in the 23S ribosomal RNA gene causing CAM resistance. This study aimed to evaluate the success rate and cost-effectiveness of tailored H. pylori eradication using DPO-PCR. METHODS: The H. pylori-positive patients diagnosed by a rapid urease test or DPO-PCR were enrolled from a single academic hospital. The patients with positive rapid urease test results received a CAM-based triple regimen. In the tailored therapy group that underwent DPO-PCR testing, patients with A2142G and/or A2143G point mutations were treated with a bismuth-containing quadruple regimen. The cost-effectiveness of H. pylori eradication success was evaluated according to the average cost per patient and the incremental cost-effectiveness ratio. RESULTS: A total of 243 patients were allocated to the triple therapy group and 124 patients to the tailored therapy group. The first-line eradication rate of H. pylori was significantly higher in the tailored therapy group than in the conventional triple therapy group (92.7% vs 76.5%, P < 0.001). The average costs per patient for tailored therapy were $307.37 and $299.59 for first-line and second-line treatments, respectively. Compared with triple therapy, the incremental cost-effectiveness ratios of tailored therapy were $3.96 and -$3.81 per patient for first-line and second-line treatments, respectively. CONCLUSION: In Korea, tailored H. pylori eradication using DPO-PCR may be more cost-effective than conventional triple therapy.

A Strategy for Helicobacter Immunohistochemistry Utilization in Pediatric Practice: Insights From Morphologic and Cost-Benefit Analyses.

OBJECTIVES: Recent studies in adults have examined the utility of immunohistochemistry (IHC) in detecting Helicobacter in gastric biopsy specimens and reached differing conclusions. Dedicated cost-benefit analysis of Helicobacter IHC in pediatric gastric biopsy specimens has not been performed. METHODS: From 1,955 pediatric gastric biopsies in a 1-year period, we identified 63 Helicobacter -positive and 120 Helicobacter -negative biopsy specimens. All cases were scored according to the Updated Sydney System for the severity of inflammation. RESULTS: We observed that pediatric Helicobacter infection was significantly associated with germinal center formation, active inflammation, oxyntic mucosa with moderate to severe chronic inflammation, and antral mucosa with any chronic inflammation, exclusive of mild and superficial chronic inflammation. At least one associated pattern was seen in each Helicobacter -positive biopsy specimen. In comparison with adults, pediatric Helicobacter -positive biopsy specimens are more likely to lack acute inflammation and more likely to show moderate to marked chronic inflammation. CONCLUSIONS: We recommend performing Helicobacter IHC on pediatric gastric biopsy specimens with any of the above inflammatory patterns. This approach can sensitively identify pediatric patients with Helicobacter gastritis, limit IHC staining to approximately 30% of all gastric biopsy specimens, and reduce costs by up to $55,306.90 per 1,000 biopsy specimens.

Prevalence of Helicobacter pylori in dyspeptic patients at a tertiary hospital in a low resource setting.

BACKGROUND: More than half of the world's population is infected with Helicobacter pylori (H. pylori), the primary cause of chronic gastritis. Chronic gastritis is associated with peptic ulcer and in advanced stages with an increased risk of developing gastric adenocarcinoma. In many developing countries access to upper gastrointestinal (UGI) endoscopy services is limited. As a result, many UGI diseases are treated empirically. OBJECTIVE: To determine the prevalence of H. pylori in patients presenting with dyspepsia, and the mean time from onset of symptoms to performing an endoscopy examination. METHODS: A cross sectional descriptive study conducted from 5th January to 30th April 2014. Adult patients with dyspepsia who were referred for UGI endoscopy were recruited consecutively. Questionnaires were used to collect data which were analyzed using STATA software. IRB approval was obtained. RESULTS: In total, 111 participants' data were analyzed. The F:M ratio was 1:1.4, mean age 43 years (SD = 16). The prevalence of H. pylori gastritis was 36%. The minimum time to endoscopy was 3 weeks, maximum 1,248 weeks and the mean time 57 weeks. CONCLUSION: The burden of H. pylori infection in patients with dyspepsia was high. Patients had prior empirical antibiotic therapy. Access to endoscopic services is limited.

[Effect on medical practices after health insurance application for "H. pylori gastritis"].

Eradication therapy for H. pylori infected gastritis became the health insurance application in Japan in 2013. It will seem that the conception of "the chronic gastritis" greatly changes from now on in Japan. "The chronic gastritis" will be classified in H. pylori gastritis and functional dyspepsia in the near future. On the other hand, it is expected that the process of the gastric cancer detection survey greatly changes too. It seems that the ABC checkup using the blood will be carried out in place of Barium examination. A decrease in gastric cancer mortality is expected as things mentioned above from now on.

The epidemiology, diagnosis, and cost of dyspepsia and Helicobacter pylori gastritis: a case-control analysis in the Southwestern United States.

BACKGROUND: Dyspepsia is among the most common complaints evaluated by gastroenterologists, but there are few studies examining its current epidemiology, evaluation, and costs. We examined these issues in a large managed care system in the Southwestern United States. METHODS: We conducted a retrospective case-control analysis of adults with incident dyspepsia or a Helicobacter pylori-related condition in years 2006 through 2010 using utilization data. Medical record abstraction of 400 cases was conducted to obtain additional clinical information. RESULTS: A total of 6989 cases met all inclusion and exclusion criteria. Women had a substantially higher risk of dyspepsia than men (14 per 1000 per year vs 10 per 1000; p < .001), and the incidence of dyspepsia increased with age such that persons in their seventh decade had almost twice the risk of those aged 18-29. Hispanic persons had a significantly higher risk of dyspepsia and positive H. pylori testing. Dyspepsia cases had a higher prevalence of other chronic comorbidities than their matched controls. Dyspepsia patients had healthcare costs 54% higher than controls even before the diagnosis was made, and costs in the initial diagnostic period were $483 greater per person, but subsequent costs were not greatly affected. Among those aged 55 and younger, the "test and treat" approach was used in 53% and another 18% had an initial esophagogastroduodenoscopy, as compared to 47 and 27%, respectively, among those over the age of 55. CONCLUSIONS: Women and older adults have a higher incidence of dyspepsia than previously appreciated, and Hispanics in this region also have a higher risk. Current guidelines for dyspepsia evaluation are only loosely followed.

Excess comorbidity prevalence and cost associated with functional dyspepsia in an employed population.

BACKGROUND: Limited published data exist on the associated comorbid conditions with functional dyspepsia (FD). AIMS: This study aimed to assess the prevalence, services, and costs related to comorbid conditions associated with FD and the risk of having FD for each comorbid condition. METHODS: A retrospective database analysis was undertaken using payroll data and adjudicated claims from January 1, 2001, through December 31, 2004 among >300,000 employees. Employees with FD were compared to propensity-score-matched employees without FD (controls). Outcome measures included the prevalence, costs, and utilization of health services for comorbid conditions as defined by the Agency for Healthcare Research and Quality (AHRQ) and the odds ratios of having FD from a multivariate model. RESULTS: FD employees (N = 1,669) and a 50:1 matched control cohort (N = 83,450) were compared. Compared to matched controls, FD employees were more likely to have all major diagnostic categories. Moreover, 199/261 of the AHRQ's specific categories were more common in the FD cohort. Annual medical costs for the FD cohort were greater than for controls in 155/261 (59%) specific categories and significantly greater (P ≤ 0.05) in 76 categories (29%). Similarly, services were greater for 179/261 (69%) specific categories and significantly greater (P ≤ 0.05) in 110 categories (42%). In a multivariate model, esophageal disorders, gastritis and duodenitis, and abdominal pain were the most associated with having FD (odds ratios 3.8, 3.7, and 3.6, respectively). Only hypertension complications and disorders of the teeth and jaw were significantly negatively associated with FD. CONCLUSION: There is unexplained excess comorbidity associated with FD which may be a major determining factor for excess healthcare services and costs.

[Strategies for extermination of gastric cancer from Japan].

To prevent deaths from gastric cancer, it is important to combine H. pylori eradication for primary prevention with endoscopic follow-up for secondary prevention. We estimated the cost of this strategy. Gastric cancer screening by simultaneous measurement of serum pepsinogen and H. pylori antibody combined with eradication of H. pylori in all individuals at risk would initially increase national healthcare expenditure, but would eventually archive great savings by markedly reducing the cost of treating gastric cancer. The proposed strategy would prevent about 150,000 deaths from gastric cancer during the 5 years after its adoption. If the loss caused by these deaths is also taken into account, the economic effect of this strategy becomes enormous. It would probably reduce the incidence of gastric cancer by more than 80-90% within 10 years. The Japanese government should take the initiative to implement this strategy as soon as possible.

Does seropositivity for Helicobacter pylori antibodies increase outpatient costs for gastric and duodenal ulcer or inflammation?

BACKGROUND: Helicobacter pylori is regarded as an important cause of both peptic ulcer and chronic gastritis. In particular, seropositivity is highest in patients with duodenal ulcer. No studies have determined whether there are differences in the direct medical costs associated with gastric/duodenal ulcer or inflammation, between seropositive and seronegative patients. OBJECTIVE: To examine the relationship between seropositivity for H. pylori and outpatient visits and direct medical costs for gastric/duodenal ulcer or inflammation in Japan from the perspective of the payor and patients. METHODS: Participants were males (n = 653) who worked for an agricultural co-operative in Fukuoka Prefecture, attended an annual health examination (including a written lifestyle and medical survey), belonged to the same health insurance society consistently for 4 years from April 1996 to March 2000, and provided a blood sample. The survey asked about lifestyle, including smoking and drinking, and past medical history. We retrospectively analysed the annual number of outpatient visits per person and outpatient medical cost (Yen, 2000 values) per person for visits relating to gastric or duodenal ulcer or inflammation using International Classification of Diseases (9th edition) -- Clinical Modification codes. We assessed for potential confounding factors using analysis of covariance and the chi-square test. RESULTS: The annual outpatient incidence of disease, the number of visits to physicians, and the medical costs for gastric or duodenal ulcer or inflammation were about 2-fold greater in individuals with antibodies to H. pylori compared with those without antibodies. CONCLUSION: Population-based studies and/or randomised controlled clinical trials that target high-risk groups and account for the unique way in which data are collected in Japan are needed to determine whether medical costs for gastric and duodenal ulcer might be reduced by treating asymptomatic patients who have antibodies to H. pylori.

The burdens of cancer therapy. Clinical and economic outcomes of chemotherapy-induced mucositis.

BACKGROUND: Mucositis is a common but poorly studied problem among patients with solid tumors. The authors examined the clinical and economic outcomes of oral and gastrointestinal (GI) mucositis among patients receiving myelosuppressive chemotherapy. METHODS: A retrospective, random sample of 599 patients who developed chemotherapy-induced myelosuppression was followed for development of oral or GI mucositis and for development of subsequent episodes of bleeding or infection. Multilevel regression models of the risk of bleeding and infection were fit with chemotherapy cycles nested within patients. RESULTS: Mucositis developed during 37% of 1236 cycles of chemotherapy. Episodes of bleeding were significantly more common during cycles with GI mucositis than during cycles without GI mucositis (13% vs. 8%; P = 0.04). Episodes of infection were significantly more common during cycles with mucositis (especially GI mucositis) than during cycles without mucositis (73% vs. 36%; P < 0.0001). The mean durations of hospitalization were 4 days, 6 days, and 12 days during cycles with no mucositis, oral mucositis, and GI mucositis, respectively. After accounting for the depth and duration of myelosuppression and for other predictive factors, GI mucositis was associated with both bleeding (odds ratio [OR], 2.0; P = 0.01) and infection (OR, 2.24; P < 0.0001), whereas oral mucositis was associated with infection only (OR, 2.4; P < 0.0001). CONCLUSIONS: Mucositis was clinically and economically significant among patients with solid tumors who were receiving myelosuppressive chemotherapy. New preventive and therapeutic agents are needed.

Helicobacter pylori eradication in patients on long-term H2 receptor antagonists. Economic and symptomatic benefits. A large prospective study in primary care.

BACKGROUND: A large proportion of patients in primary care are still being maintained on long-term acid suppression, without any attempts to identify Helicobacter pylori status and to treat those that test positive. OBJECTIVES: To assess the prevalence and economic and symptomatic benefits of H. pylori eradication in patients maintained on long-term H2 receptor antagonists (H2RA) in primary care. PATIENTS AND METHODS: Patients on long-term (i.e. 6 months or longer) H2RA were identified from the computerised records of six practices in north England. Helicobacter pylori status was identified using serology and H. pylori positive patients were then offered standard 7-day proton pump based triple therapy, followed by a urea breath test (UBT) to confirm H. pylori eradication. Those who had a positive UBT were offered a second line course of H. pylori eradication therapy. Follow up period was 1 year. The main outcome measures were improvement in dyspepsia symptom scores, amount of H2RA being consumed, and economic benefits after H. pylori eradication. RESULTS: One thousand and seven patients (1.5%) were identified on long-term H2RA, of whom 471 (46%) ultimately had their H. pylori serology assessed. Sixty-three (297) percent of the patients tested had a positive serology for H. pylori, the majority of whom (58%, 172) had prior evidence of peptic ulcer disease. The mean duration of therapy and mean time since endoscopy/barium studies was significantly longer in patients with peptic ulcer disease compared to their counterparts with nonulcer dyspepsia and gastro-oesophageal reflux disease, p =.0002 and.0001, respectively. After successful H. pylori eradication (which was possible in 84% of the patients), at the end of the 1-year study period, on an intention to treat basis 62% of the patients could either stop or significantly reduce dosage of their H2RA. There was also significant reduction in the mean dose of H2RA being consumed and severity of symptoms at the end of the study period (p <.00001). CONCLUSION: Almost two-thirds of patients on long-term H2RA in primary care will have a positive serology for H. pylori; the majority of these will have peptic ulcer disease. In over 60% of cases H. pylori eradication led to significant improvement in symptom scores and reduction in dosage of H2RA being consumed. Cessation or reduction in long-term H2RA prescribing is cost effective.

Economic burden of NSAID-induced gastropathy in Sweden.

BACKGROUND: Gastrointestinal side effects carry a significant cost related to the use of NSAID medications. METHODS: The economic burden of NSAID-induced gastric side effects is estimated using the cost-of-illness methodology. Costs are calculated using both a prevalence (top-down) approach and an incidence (bottom-up) approach. RESULTS: Using the top-down approach, the total cost in 1998 of NSAID-induced ulcers was MSEK 329-586, direct costs accounting for 76%-83%. The bottom-up approach gives an estimate of MSEK 320, of which MSEK 290 was direct cost. About one-quarter of total costs for ulcer disease can be attributed to the use of NSAIDs. CONCLUSIONS: Gastrointestinal side effects carry a significant cost from the use of NSAIDs, costs that are as important as the price of NSAIDs. This should be considered when choice of drug and prophylaxis is being made.

Isotope ratio mass spectrometry (IRMS) versus laser-assisted ratio analyzer (LARA): a comparative study using two doses of.

This study was carried out to compare the measurements and the diagnostic accuracy of the traditional expensive IRMS and the new economical LARA system using two doses of [13C]urea + two different test meals in patients undergoing upper gastrointestinal endoscopy, both before and after anti-Helicobacter treatment. A total of 354 dyspeptic patients underwent endoscopy with gastric biopsies to diagnose H. pylori infection by CLO-test and histology. No patients had taken antibiotics, bismuth, or antisecretory drugs in the 4 weeks before testing. After overnight fasting, breath samples were collected simultaneously in both plastic and glass tubes at baseline and at 30 and 60 min after urea ingestion. In 237 patients 100 mg [13C]urea + Ensure and in 117 patients 75 mg [13C]urea + citric acid were given. The test was also performed with the two urea dosages and meals in 67 and 64 infected patients, respectively, four weeks after anti-Helicobacter therapy. H. pylori was considered eradicated when both biopsy-based tests were negative. A delta value >5 per thousand was considered positive. Breath samples with insufficient CO2 levels at both 30 and 60 min were excluded from final analysis (N = 37 in pre- and N = 8 in posttreatment). There was excellent agreement between overall delta values of the two machines with both [13C]urea 100 mg + Ensure and [13C]urea 75 mg + citric acid. The 95% CI of the difference against the mean was wider with the former (mean -1.3, +6.3, and -9.4) than with the latter urea dosage and test meal (mean -1.2, +5.2 and -8.1). LARA and IRMS were equally effective (P = NS) in distinguishing infected from uninfected patients before therapy using both doses of [13C]urea and test meals (sensitivity ranged from 95% to 99% and specificity from 95% to 97%). This good performance was maintained in the posttreatment phase (sensitivity ranged from 90% to 100% and specificity from 90% to 97%), without any statistical difference among the various combinations (P = NS). The LARA system is a valid alternative to IRMS in the diagnosis of H. pylori infection. Both machines provide highly reliable results after 30 min, so that the 60 min sample can be avoided. The dose of 75 mg + citric acid suffices to ensure an accurate UBT. The test performed with both devices and [13C]urea dosages is very effective also for posttherapy evaluation of H. pylori status.

Probabilistic sensitivity analysis incorporating the bootstrap: an example comparing treatments for the eradication of Helicobacter pylori.

Decision-analytic models are frequently used to evaluate the relative costs and benefits of alternative therapeutic strategies for health care. Various types of sensitivity analysis are used to evaluate the uncertainty inherent in the models. Although probabilistic sensitivity analysis is more difficult theoretically and computationally, the results can be much more powerful and useful than deterministic sensitivity analysis. The authors show how a Monte Carlo simulation can be implemented using standard software to perform a probabilistic sensitivity analysis incorporating the bootstrap. The method is applied to a decision-analytic model evaluating the cost-effectiveness of Helicobacter pylori eradication. The necessary steps are straightforward and are described in detail. The use of the bootstrap avoids certain difficulties encountered with theoretical distributions. The probabilistic sensitivity analysis provided insights into the decision-analytic model beyond the traditional base-case and deterministic sensitivity analyses and should become the standard method for assessing sensitivity.

[Antibiotic resistance of Helicobacter pylori in an infectious disease referral center]. / Resistencia a antimicrobianos de Helicobacter pylori en un centro de referencia infectológico.

OBJECTIVE: To estimate the frequency of H. pylori clinical isolates resistant to six commonly used antimicrobials. DESIGN: Cross-sectional observational study. SETTING: A tertiary-referral health care institution in Mexico City. PARTICIPANTS: 31 isolates of H. pylori from 31 patients with chronic antral gastritis were obtained from gastric mucosal biopsy specimens. MAIN OUTCOME MEASURE: The Minimum Inhibitory Concentration (MIC) to ampicillin, amoxycillin, tetracycline, doxycycline, metronidazole and to colloidal bismuth subcitrate was determined by the agar plate dilution test. RESULTS: All isolates showed to be susceptible to the former four antibiotics but only in 46% and 55% growth was inhibited by 8 micrograms/mL and 16 micrograms/mL of metronidazole, respectively. All isolates were inhibited by < or = 128 micrograms/mL of bismuth. A 50% increase in the percentage of metronidazole-resistant isolates (MIC > or = 8 micrograms/mL) between 1988 to 1992 was observed. CONCLUSION: There is a need of future studies in our setting aimed at assessing the cost/effectiveness of diverse H. pylori-associated peptic ulcer treatment options.

Accuracy and economics of Helicobacter pylori diagnosis.

Many diagnostic tests are available to establish Helicobacter pylori infection status. Most of the tests are accurate though none works perfectly, and no gold standard for diagnosis exists. Newly developed serum immunoassay kits can substitute for laboratory-based enzyme-linked immunosorbent assays, but whole blood immunoassays do not yet demonstrate adequate performance characteristics. Serologic diagnosis of H. pylori remains the most cost-effective option and should be utilized to establish initial infection in the majority of cases. If rapid urease testing is performed at endoscopy, negative results can be confirmed with a subsequent serologic test in those patients with a high probability of infection. Obtaining additional gastric tissue at endoscopy to evaluate for bacterial infection is reasonable if specimens are being taken for a mucosal defect. Confirmation of bacterial eradication cannot be justified for all post-treatment patients at present due to the expense. It is important to test for cure in those patients with complicated ulcer disease and those with recurrent symptoms after therapy.

Costs of acid-related disorders to a health maintenance organization.

BACKGROUND: Little is known about the economic impact of the acid-related disorders (ARDs), which include dyspepsia, gastritis, gastroesophageal reflux disease (GERD), and peptic ulcer disease (PUD), in managed care patient populations. OBJECTIVES: To describe the prevalence of medically attended ARDs, and their direct medical costs from the perspective of a large health maintenance organization (HMO). METHODS: A total of 1,550 ARDs subjects (age > or = 18 years), were randomly sampled from outpatient diagnosis and pharmacy databases of the Kaiser Permanente Medical Care Program of Northern California and verified by chart review. Five age- and gender-matched controls were identified per subject. One-year prevalence, excess annual costs, and initial 6-month costs for incident cases were estimated using the HMO cost accounting system. RESULTS: Total ARDs prevalence (5.8%) increases with advancing age. GERD is the most common ARD (2.9% overall prevalence). Annual per person attributable costs were $1,183, $471, and $431 respectively for PUD, GERD, and gastritis/dyspepsia. Excess inpatient costs for PUD explain its higher costs. Outpatient costs were somewhat higher for GERD ($279) than for PUD or gastritis/dyspepsia. Pharmacy costs were relatively low for each condition, in part because many patients were treated with generic cimetidine. Total annual HMO expenditures for ARDs were $59.4 million, with 40.6%, 36.8%, and 22.6% respectively for GERD, PUD, and gastritis/dyspepsia. CONCLUSIONS: Acid-related disorders, particularly GERD and PUD, contribute substantially to the direct costs of medical care in this managed care population.

Cost of acid peptic disorders in a managed-care organization.

The purpose of this study was to determine the cost of managing ambulatory patients with symptoms of acid peptic disorders in a managed-care organization under actual clinical conditions. Study data were collected in a large independent practice association model health maintenance organization in Gainesville, Florida, from prescription records maintained in a computerized database and from patient medical records. Patients had to be started on a histamine2-receptor antagonist (H2RA) or the proton pump inhibitor omeprazole between 1992 and 1994. A total of 113 patients qualified for inclusion in the study; 57 received H2RAs, 27 received omeprazole, and 29 received combination therapy. The costs of procedures, physician visits, and drug therapy were considered in the economic evaluation. Costs were evaluated using two methods: the capitation total cost (CTC) and the fee-for-service total cost (FSTC). The mean CTC and FSTC for managing a patient with acid peptic symptoms for 6 months were $382 +/- 356 (range, $14 to $1820) and $456 +/- 368 (range, $52 to $1925), respectively. Drug costs represented 52% of the total FSTC and 62% of the total CTC. Drug costs were followed by the costs for encounters with primary care physicians, endoscopy, referral to specialists, and upper gastrointestinal (UGI) tract procedures. Documented outcomes were available for 85 patients. Compared with patients receiving H2RAs (n = 41), patients receiving omeprazole (n = 18) had significantly lower FSTCs ($317 +/- 219 compared with $423 +/- 307, respectively); diagnostic testing costs (for endoscopy, $0 compared with $44 +/- 119, respectively; for UGI procedures, $22 +/- 42 compared with $55 +/- 54, respectively); physician encounter costs ($66 +/- 40 compared with $86 +/- 38, respectively); and referral to specialist costs ($0 compared with $18 +/- 60, respectively). Patients receiving omeprazole also had more positive clinical outcomes than patients receiving H2RAs (78% compared with 49%, respectively), resulting in a more favorable cost of producing a successful outcome compared with patients receiving an H2RA. The cost of success was $407 for patients treated with omeprazole compared with $869 for patients treated with H2RAs. The findings of this analysis conducted under actual clinical conditions support findings of randomized clinical trials showing the cost-effectiveness of proton pump inhibitors.